FDA 510K

FDA 510k - A Complete Overview

The technical dossier for devices intended for human use that must be submitted to the US Food and Drug Administration (FDA) is known as an FDA 510k. A medical device maker or specification developer submits an application to the FDA to show that the device to be marketed is as safe and effective as, or substantially equal to, a lawfully marketed product in the United States.

A description of the medical device, models, and accessories or components that come into direct touch with patients, as well as device performance specifications, must be included in the 510(k) paperwork. A 510(k) number, or 510k approval, is issued once the FDA decides that the submitted device is substantially comparable. It’s not the same as an FDA 510k approval.

A Pre-market Notification is another name for a 510k submission. This contains information about the medical device’s technical specifications, performance, and safety. Manufacturers that want to sell their medium-risk medical device or IVD in the United States must submit a submission for products that do not require a Premarket Approval (PMA) and are not excluded from the 510k criteria. A Pre-market Notification is another name for a 510k submission.

The 510(k) regulatory paperwork must show that the proposed device is at least as safe and effective as a lawfully marketed device in the United States. A medical device that has previously acquired 510k approval for sale in the United States is known as a legally marketed product.

The similarities and differences between the proposed device and the predicate device must be examined, and appropriate laboratory testing must be undertaken to show significant equivalence. In most cases, human testing is not required as part of FDA 510k filings. Most Class II medical devices, Class I and Class III medical devices, including IVDs require submissions.

There are three sorts of 510ks in general: (1) 510(k) abbreviated (2) 510(k) traditional (3) 510(k) special (k). More information is available in the article section below.


  • Class I: Simple risk-free devices. The majority of the class 1 devices are subjected to general regulatory controls and do not require any 510(k) clearance.
  • Class II: Devices pose a moderate level of risk to the user. The majority of the class II devices require a 510(k) submission and clearance before being legally marketed.
  • Class III: Devices pose a high risk to the user and could lead to significant adverse outcomes for the patients. Most class III devices require a 510k submission, and a few require PMA submission before being marketed in the USA.

>>>FDA Device Classification<<< 

  • 510k technical documentation
  • Device Testing
  • Demonstration of Substantial equivalence
  • FDA Review Fees payment and 510(k) submission

Some of the applicants will do pre-submission to FDA to avoid any undue surprise rejection in the last stage. Careful planning, strategic decisions, and expertise of our consultants will ensure the early acceptance of the 510k file without RTA or AI and the successful clearance of the 510k submission.

Premarket Notification or PMN or 510(k) is not a Certification issued by FDA to your devices, unlike CE Mark Certificate issued by Notified Bodies in Europe. Once you demonstrate the substantial equivalence with already 510k cleared device, FDA gives 510(k) approval or clearance.

Under a realistic approach, manufacturers and applicants must grasp the timetable.

Depending on the device's nature and variations, FDA 510k preparation can take anywhere from 3 to 6 months, including external testing.
The US Congress has set a 90-day deadline for reviewing a 510k file; nevertheless, based on our experience and calculations, most 510k file evaluations and final decisions can take anywhere from 140 to 200 days.

The consultant's involvement is critical in ensuring a successful 510(k) application and approval. We offer the following services to our customers in order to decrease the cost, time, and failures associated with 510k submissions.

Submission of a pre-510(k) Analysis of Gaps
Compilation of documents and FDA 510K (pre and original) filing
Only the services of a US agent and a submission service are available.

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The FDA 510(k) must be of the highest possible standard!!! In terms of less review comments and approval times. Preparing an FDA 510(k) technical file may be challenging because to the stricter file structure requirements, which include 17 unique modules to meet each 510(k) need. All relevant protocols, test results, and other supporting documents are provided in defined annexures, with correct file numbers and names. The bulk of 510(k)s are longer than 250 pages. The FDA 510k must fulfil the FDA's eCopy filing requirements.

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